A Clinical Trial of MK-7262 and Enlicitide in Participants With High Lipoprotein(a) (MK-7262-004)

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-7262 as Monotherapy and When Coadministered With Enlicitide Decanoate in Adults With Elevated Lipoprotein(a)

Researchers designed a trial medicine called MK-7262 to lower levels of Lp(a) in the blood. Researchers want to learn about giving MK-7262 with another trial medicine called enlicitide (also known as MK-0616 or enlicitide decanoate). Enlicitide is in a group of medicines that lower the amount of low-density lipoprotein cholesterol (LDL-C).

The goals of this trial are to evaluate:

• if MK-7262 and enlicitide taken together work better than placebo at lowering Lp(a) and LDL-C levels in the blood
• if MK-7262 alone works better than placebo at lowering Lp(a) levels in the blood
• the safety and tolerability of taking MK-7262 and enlicitide alone and together

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

• Has Lp(a) ≥ 150 nmol/L
• Is receiving an optimized and stable dose of statin for ≥ 30 days with no planned additions, dose changes, or discontinuations through the duration of the study

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

• Has a history of homozygous familial hypercholesterolemia (FH), compound heterozygous FH, or double heterozygous FH
• Has a history of class IV heart failure, severe ventricular systolic dysfunction, uncontrolled ventricular arrhythmia, markedly prolonged corrected QT interval, untreated hypertension, or a recent coronary, cerebrovascular, or peripheral ischemic event or arterial revascularization
• Has human immunodeficiency virus infection, unless the infection is controlled (i.e. undetectable viral load)
• Has an active hepatitis C virus infection or active or chronic hepatitis B virus infection
• Has a history of nephrotic syndrome
• Has severe renal insufficiency
• Has received certain therapies in the prohibited timeframe as specified in the protocol
• Has active or chronic hepatobiliary or hepatic disease
• Has poorly controlled Type 1 or Type 2 diabetes